DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 05/31/2023 has been entered. Claims 4, 5, 10-12, 14, 16, 17, 19, 20, 22, 24-35, 37, 39, 42, 46-57, and 59-65 are cancelled. Claims 1-3, 6-9, 13, 15, 18, 21, 23, 36, 38, 40, 41, 43-45, and 58 are pending in this application. Claims 2, 3, 6, 7, 15, 18, 43, and 58 are withdrawn. Claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 are currently under examination.
Priority
This application is a 371 of PCT/GB2021/051458 filed on 06/11/2021 and claims foreign priority of UNITED KINGDOM 2008919.9 filed on 06/11/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. UNITED KINGDOM 2008919.9, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 44 and 45 recite “a non-sulphated fluid gel” and/or a non-sulphated polymer”, which are not disclosed or supported by the prior-filed application, Application No. UNITED KINGDOM 2008919.9. Thus, the priority date of claims 44 and 45 is 06/11/2021.
Election/Restrictions
Applicant's election without traverse of Group I invention (claims 1, 8, 9, 13, 15, 18, 21, 23, 36, 38, 40, 41, and 43-45) and species (A. One specific sulphated polysaccharide: carrageenan; B. One specific shear-thinning fluid gel: gellans) in the reply filed on 01/06/2026 is acknowledged. Claims 2, 3, 6, 7, 15, 18, 43, and 58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/09/2022, 05/31/2023, 04/15/2025, and 07/09/2025 with appropriate assertion under 37 CFR 1.98 have been considered.
Claim Objections
Claims 38 and 40 are objected to because of the following informalities: In claim 38, insert the missing word “hydrogel” immediately before the recitation “composition” (line 4) to tie with the preceding “a shear-thinning hydrogel composition” (line 2). In claim 40, delete one of the redundant “agarose,” (line 3). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13, 21, 23, 36, 38, 41, and 45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 13, 21, 23, 36, and 41 recite the broad recitation “a molecular weight of between 5 and 1,000 kDa” (line 2 of claim 13), “between 15% and 40% estersulphate” (line 2 of claim 21), “poligeenan; furcellaran; and a carrageenan” (lines 2 to 3 of claim 23), “a viscosity of 0.1 Pa.s or greater” (line 2 of claim 36), or “gellan” (line 2 of claim 41), and the claim also recites “optionally… a molecular weight of between 8 and 800 kDa” (line 3 of claim 13), “optionally… between 20% and 35% estersulphate” (lines 2 to 3 of claim 21), “optionally… the poligeenan has a molecular weight of between 20 and 30 kDa… optionally… the furcellaran has a molecular weight of between 20 and 80 kDa… optionally… iota carrageenan; kappa carrageenan; and lambda carrageenan… optionally… average sulphate number per disaccharide unit of the iota carrageenan is 2… optionally… average sulphate number per disaccharide unit of the kappa carrageenan is 1… optionally… average sulphate number per disaccharide unit of the lambda carrageenan is 3” (lines 3-16 of claim 23), “optionally… a viscosity of 5 Pa.s or greater” (line 4 of claim 36), or “approximately 0.9% w/v of gellan” (line 3 of claim 41) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: The recitation “the sulphated polysaccharide is selected from the group consisting of: poligeenan; furcellaran; and a carrageenan” (lines 1 to 3), in which the Markush group format limits the recited sulphated polysaccharide, whereas the subsequent recitation “the sulphated polysaccharide comprises poligeenan… comprises furcellaran… comprises a carrageenan… comprises iota carrageenan… comprises kappa carrageenan… comprises lambda carrageenan”, in which the open-ended “comprises” would allow additional sulphated polysaccharide and/or other substances. Thus, the recitation “selected from the group consisting of”, followed by “comprises” omits structural cooperative relationships.
Regarding claim 38, the phrase "such as" (line 3) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 45 recites the limitation "the microgel particle forming polymer" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Taken together, Applicant is advised to change the recitation “optionally” (line 3 of claims 13, 23, and 36; line 2 of claims 21 and 41) to conjunction “or”; to delete the recitations “the sulphated polysaccharide comprises poligeenan, optionally wherein” (line 4 of claim 23), “the sulphated polysaccharide comprises furcellaran, optionally wherein” (line 6 of claim 23), “the sulphated polysaccharide comprises a carrageenan, optionally wherein” (line 8 of claim 23), “optionally” (line 10 of claim 23), “the carrageenan comprises iota carrageenan, optionally wherein” (line 8 of claim 23), “the carrageenan comprises kappa carrageenan, optionally wherein” (line 11 of claim 23), and “the carrageenan comprises lambda carrageenan, optionally wherein” (line 13 of claim 23); to change the recitation “(such as 0.1 to 5% w/v, or 0.1 to 2.5% w/v) of” (line 3 of claim 38) to “, 0.1 to 5% w/v, or 0.1 to 2.5% w/v of”; and to replace the recitation “to any of claim 1” (line 1 of claim 45) with “to claim 40”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 recite a composition comprising a sulphated polysaccharide (or an average sulphate number per repeating saccharide unit of between 1 and 3; or a carrageenan, elected; or a molecular weight of between 5 and 1,000 kDa; or comprising between 15% and 40% estersulphate by weight; or kappa, iota, or lambda carrageenan, wherein the average sulphate number per disaccharide unit of the kappa, iota, or lambda carrageenan is 1, 2, and 2, respectively) and a shear-thinning fluid gel (or having a viscosity of 0.1 Pa.s or greater; or comprising 0.1 to 10% w/v, 0.1 to 5% w/v, or 0.1 to 2.5% w/v of a microgel particle forming polymer dispersed in an aqueous medium; or comprising a microgel particle forming polymer selected from gellans, elected; or non-sulphated fluid gel; or non-sulphated polymer), which are products of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is determined that this judicial exception is not integrated into a practical application because there is no indication that mixing them in the recited amount (i.e., 0.1 to 10% w/v, 0.1 to 5% w/v, or 0.1 to 2.5% w/v) changes the structure, function, or other properties of the sulphated polysaccharide and shear-thinning fluid gel in any marked way. Instead, the sulphated polysaccharide or shear-thinning fluid gel retains its naturally occurring structure and properties (e.g., gelling or viscosity-adjusting substance). Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, mixing of the sulphated polysaccharide and shear-thinning fluid gel was well-understood, routine and conventional in the field, as evidenced by the reference under the 102 rejection below. The recitation of specific amounts or properties of the sulphated polysaccharide and shear-thinning fluid gel does not affect this analysis, because it was also well-understood, routine and conventional at the time to mix specific amounts of the sulphated polysaccharide and shear-thinning fluid gel, e.g., to achieve commercially acceptable chemical complex for different purposes. Thus, the mixing of different amount of the sulphated polysaccharide and shear-thinning fluid gel, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(I) Claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 are rejected under 35 U.S.C. 102(1) as being anticipated by Ahmed et al. (International Journal of Drug Delivery Technology 8(2):80-89, 2018, hereinafter referred to as Ahmed ‘2018, also listed in IDS filed on 12/09/2022) as evidenced by Gelrite (Duchefa Biochemie, Revision date: 08/05/2023 Supersedes version of: 22/09/2017) and Campo et al. (Carbohydrate Polymers 77:167–180, 2009, hereinafter referred to as Campo ‘2009).
With regard to structural limitations “a pharmaceutical composition comprising a sulphated polysaccharide (or an average sulphate number per repeating saccharide unit of between 1 and 3; or a carrageenan, elected; or a molecular weight of between 5 and 1,000 kDa; or comprising between 15% and 40% estersulphate by weight; or kappa carrageenan, wherein the average sulphate number per disaccharide unit of the kappa carrageenan is 1) and a shear-thinning fluid gel (or having a viscosity of 0.1 Pa.s or greater; or comprising 0.1 to 10% w/v, 0.1 to 5% w/v, or 0.1 to 2.5% w/v of a microgel particle forming polymer dispersed in an aqueous medium; or comprising a microgel particle forming polymer selected from gellans, elected; or non-sulphated fluid gel; or non-sulphated polymer)” (claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45):
Ahmed ‘2018 disclosed a formulation of In-situ gel of Brimonidine tartarate (BT), anti-glaucoma agent using Ion activated polymer; Gelrite as gelling agent, kappa carrageenan as mucoadhesive agent and Hydroxy Propyl Methyl Cellulose (HPMC E50) as release retardant polymer. The formulation containing concentration Gelrite (0.39%), kappa carrageenan (0.21%) and HPMC E50 (0.4%) was found to be optimized formulation (page 80, Abstract). Procedure for preparation of in-situ gels: Added required quantity of gelrite polymer to the borate buffer solution and heated to about 70 oC until it is completely dissolved. To the prepared gelrite solutions, required quantity of kappa carrageenan was added and stirred well on magnetic stirrer with slight heating. To the above prepared gelrite/mucoadhesive solution, required quantity of drug (0.2% Brimonidine tartarate) was added with continuous stirring until it is thoroughly mixed. HPMC E LV 50 and phenyl ethyl alcohol were added and stirred on magnetic stirrer. pH was checked and adjusted with the buffer. Table 2: Compositions of Different Polymer Concentrations.
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(page 81, left col., para. 1; page 82, Table 2). Gelrite (cited here as evidence for the gellan gum) disclosed that the Gelrite is a tradename for gellan gum (page 1/9). Campo ‘2009 (cited here as evidence for the kappa carrageenan) disclosed that commercial carrageenans have an average molecular mass ranging between 100 and 1000 kDa. The kappa (κ)-, iota (ι)- and lambda (λ)-carrageenan dimers have one, two and three sulphate ester groups, respectively, resulting in correspondent calculated sulphate contents of 20%, 33% and 41% (w/w). Typically, commercial κ-carrageenan contains 22% (w/w) of sulphate, ι-carrageenan 32% (w/w) and λ-carrageenan 38% (w/w) (page 168, right col., para. 1 to 2).
Thus, these teachings of Ahmed ‘2018 as evidenced by Gelrite and Campo ‘2009 anticipate Applicant’s claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45.
(II) Claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 are rejected under 35 U.S.C. 102(1) as being anticipated by Osmałek et al. (Journal of Biomaterials Applications 33(1):140–155, 2018, hereinafter referred to as Osmałek ‘2018) as evidenced by Campo et al. (Carbohydrate Polymers 77:167–180, 2009, hereinafter referred to as Campo ‘2009).
With regard to structural limitations “a pharmaceutical composition comprising a sulphated polysaccharide (or an average sulphate number per repeating saccharide unit of between 1 and 3; or a carrageenan, elected; or a molecular weight of between 5 and 1,000 kDa, for example, carrageenan or dextran sulphate; or comprising between 15% and 40% estersulphate by weight; or iota carrageenan, wherein the average sulphate number per disaccharide unit of the iota carrageenan is 2) and a shear-thinning fluid gel (or comprising 0.1 to 10% w/v, 0.1 to 5% w/v, or 0.1 to 2.5% w/v of a microgel particle forming polymer dispersed in an aqueous medium or further comprising 0.5 to 100 mM polyvalent metal ion salt; or comprising a microgel particle forming polymer selected from gellans, elected; or non-sulphated fluid gel; or non-sulphated polymer)” (claims 1, 8, 9, 13, 21, 23, 38, 40, 41, 44, and 45):
Osmałek ‘2018 disclosed formulation and evaluation of novel naproxen-loaded macrobeads, made on the basis of low-acyl gellan gum and its blends with carrageenans, cellulose sulfate, and dextran sulfates. The percent amounts of the ingredients in seven mixtures (F1–F7) are presented in Table 1:
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(P1: Low-acyl gellan gum; Commercially available iota carrageenans P2: Santiagum® MM30 and P3: Ricovis® 8870; P4: Cellulose sulphate sodium salt; dextran sulphate sodium salt made from dextran with weight average molecular weight either P6: 500,000 g/mol or P7: 5000 g/mol). First, the polymer was poured on the surface of deionized water (ambient temp.) in an Erlenmeyer flask and left to moisten and swell. The flask was closed with a rubber septum to avoid evaporation of water. After 10 min the temperature increased to 80.0 ± 2.0 oC under constant stirring on a RET control-visc magnetic stirrer. When a clear polymer solution was obtained, the temperature decreased to 70oC and Tween 80 was added. After 2 min NPX was carefully poured and the mixing continued until a homogenous suspension was achieved. The drug-polymer mixture was transferred to the solution of calcium chloride (9.0 x 10-2 M) through Var J1 encapsulation unit (page 140, Abstract; page 142, right col., para. 1 to 2; page 143, Table 1). Campo ‘2009 (cited here as evidence for the iota carrageenan) disclosed that commercial carrageenans have an average molecular mass ranging between 100 and 1000 kDa. The kappa (κ)-, iota (ι)- and lambda (λ)-carrageenan dimers have one, two and three sulphate ester groups, respectively, resulting in correspondent calculated sulphate contents of 20%, 33% and 41% (w/w). Typically, commercial κ-carrageenan contains 22% (w/w) of sulphate, ι-carrageenan 32% (w/w) and λ-carrageenan 38% (w/w) (page 168, right col., para. 1 to 2).
Thus, these teachings of Osmałek ‘2018 as evidenced by Campo et al. anticipate Applicant’s claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 and would also carry the same property, including “the shear-thinning fluid gel has a viscosity of 0.1 Pa.s or greater when exposed to zero shear”, required by claim 36, because the w/v of the shear-thinning fluid gel of gellan gum is encompassed by the claimed w/v in claim 38.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, and 9 of copending Application No. 19/505,239 (Grover et al., the claim set of 01/23/2026) as evidenced by Campo et al. (Carbohydrate Polymers 77:167–180, 2009, hereinafter referred to as Campo ‘2009). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘239 claims “A formulation comprising: polysaccharide aggregates suspended in an aqueous medium; and a salt (or comprising divalent cations, optionally wherein the divalent cations are calcium ions; or at a concentration of from 0.01 M to 0.5 M), wherein the only polysaccharide(s) (or selected from carrageenan, gellan, dextran sulphate, alginate, pectin, xanthan gum, gum Arabic, carboxymethyl cellulose, heparin, heparan sulphate, chondroitin sulphate, hyaluronic acid, keratan sulphate, dermatan sulphate and mixtures thereof; or carrageenan, optionally iota carrageenan; at a concentration of at least 0.000125 %w/v) present in the formulation is(are) the polysaccharide(s) which form(s) the aggregates” (claims 1, 3-5, 8, and 9). Campo ‘2009 (cited here as evidence for the iota carrageenan) disclosed that commercial carrageenans have an average molecular mass ranging between 100 and 1000 kDa. The kappa (κ)-, iota (ι)- and lambda (λ)-carrageenan dimers have one, two and three sulphate ester groups, respectively, resulting in correspondent calculated sulphate contents of 20%, 33% and 41% (w/w). Typically, commercial κ-carrageenan contains 22% (w/w) of sulphate, ι-carrageenan 32% (w/w) and λ-carrageenan 38% (w/w) (page 168, right col., para. 1 to 2). Thus, claims 1, 3-5, 8, and 9 of copending Appl ‘239 overlap with claims 1, 8, 9, 13, 21, 23, 36, 38, 40, 41, 44, and 45 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691